Method for preparing a medical solution for the manufacture of a medicament for peritoneal dialysis

ABSTRACT

A method for preparing a medical solution, comprising the steps of a) providing a solution comprising one or more acetylated or deacetylated amino sugar/sugars in at least one compartment of a container in a concentration from 15% by weight to 40% by weight, with the basis of the solution in said at least one compartments, and b) terminal sterilisation of said at least one compartment and the contents therein, is disclosed, as well as a solution used for preparing the medical solution, a container containing said solution, and use of said solution for the manufacture of a medicament for peritoneal dialysis.

BACKGROUND OF THE INVENTION

The present invention relates to a method for preparing a medicalsolution, a solution used for preparing the medical solution, acontainer containing said solution, and use of said solution for themanufacture of a medicament for peritoneal dialysis.

BACKGROUND ART

N-acetylglucosamine (NAG) and glucosamine are biochemically classifiedas amino sugars. Amino sugars are formed in almost all cells from bloodglucose through a series of biochemical reactions. Hyaluronan is apolymer composed of dimers containing N-acetylglucosamine and glucuronicacid. It has been shown that the function of the peritoneum as adialysis membrane is better preserved in rats that have been chronicallydialyzed with fluid supplemented with exogenous hyaluronan (seeWieczorowska K, Breborowicz A et al, Protective effect of hyaluronicacid against peritoneal injury, Perit Dial Int 1995; 15:81-83).

Breborowicz A, Kuzlan-Pawlaczyk M et al, The Effect ofN-Acetyl-glucosamine as a Substrate for In Vitro synthesis ofGlycosaminoglycans by Human Peritoneal Mesothelial Cells andFibroblasts, Advances in Peritoneal Dialysis, 1998; 14:31-35, teachesthat NAG rapidly stimulates the production of hyaluronan and sulphatedglycosaminoglycans by human peritoneal mesothelial cells andfibroblasts.

Wu G, Wieczorowska-Tobis K, et al, N-acetylglucosamine changespermeability of peritoneum during chronic peritoneal dialysis in rats,Perit Dial Int, 1998; 18:217-224 concludes that peritoneal dialysis witha dialysis solution supplemented with N-acetylglucosamin causesaccumulation of glucosaminoglycans in the peritoneal interstitium,resulting in a favorable change of the peritoneal permeability.

Breborowicz, M et al discloses replacement of glucose withN-acetylglucosamine in peritoneal dialysis fluid.

U.S. Pat. No. 5,536,469 discloses a system employing a sterile medicalsolution containing glucose or glucose-like compounds and a solutionintended for said system.

Due to its advantageous characteristics, NAG has been introduced as acomponent in peritoneal dialysis solutions replacing part or all of theglucose component with a view to obtaining a more biocompatibleperitoneal dialysis solution (see WO97/06810).

Peritoneal dialysis is a method for exchanging solutes and water incapillary vessels of a patient's peritoneum with hypertonic solution,which is infused into the peritoneal cavity. The principle of thismethod is diffusion of solutes transferred according to theconcentration gradient and water migration due to osmotic differences.This method has many advantages, e.g. that no special apparatus iscommonly required. It gives less influence on the hemodynamics becauseextracorporeal circulation of the patient's blood is not necessary, andfurther the peritoneal dialysis is a continuous treatment and thereforemore similar to the function of the kidneys.

Peritoneal dialysis is usually classified as continuous ambulatoryperitoneal dialysis (CAPD), intermittent peritoneal dialysis (IPD),continuous cyclic peritoneal dialysis (CCPD) or automated peritonealdialysis (APD).

In CAPD a catheter is permanently implanted in the abdominal wall of thepatient and about 1.5 to 2.5 l of the dialysis fluid is normallyintroduced via the catheter into the peritoneal cavity. The peritonealcavity is flooded with this fluid, left for an appropriate lapse of timeand then drained. Removal of solutes and water takes place across theperitoneum, which acts as a semipermeable membrane.

The dialysis fluid normally used for peritoneal dialysis is an aqueoussolution comprising an osmotic agent such as glucose and the like,electrolytes such as sodium, potassium, calcium, magnesium, and organicacid salts such as sodium lactate, sodium bicarbonate, or sodiumpyruvate. The components of these peritoneal dialysis fluids areselected to control the levels of electrolytes or the acid-baseequilibrium, to remove waste materials and to efficiently carry outultrafiltration.

It is known to pack medical solutions in multicompartment bags from e.g.WO 99/27885 (Gambro Lundia AB), in which different solutes may be keptin separate compartments of the bag with a view to, inter alia,regulating the concentration of active ingredients in the finallyprepared solution. Medical fluids are normally sterilised by heat.

Medical authorities in many countries require sterilisation after finalpackaging of the medical product. It is therefore often not possible tosterile filter the solution.

However, a problem with the formation of undesired cytotoxic productsduring heat sterilisation and storage exists for a variety of medicalsolutions, inter alia within the dialysis area, e.g. for peritonealdialysis solutions. It is known e.g. from EP-B1-0 668 785 (Gambro LundiaAB) to reduce the amount of toxic degradation products from glucose orglucose-like compounds in a medical solution.

It has now been found that also amino sugars, e.g. NAG, in conventionalmedical solutions exhibit an increased cytotoxicity after heatsterilisation. This cytotoxicity depends on the formation of toxicdegradation products from said amino sugars. In contrast to glucose,none of the known glucose degradation products has been found in heatsterilised NAG solutions. This fact has not been known previously andforms the basis for the present invention.

NAG and other amino sugars have a major difference from glucose andglucose-like compounds by having one amino group and possibly an acetylgroup coupled to the glucose ring. Regarding the degradation process, ithas been found that the pH of a NAG solution increases duringsterilisation while in the case of glucose it decreases duringsterilisation. This indicates that NAG is, in contrast to glucose,degraded by a hydrolysis that forms acetate, which increases the pH.

Thus, there is a need to solve the above defined problem and to providea medical solution containing amino sugars, in particular NAG, andderivatives thereof and at the same time having the ability to be heatsterilised without the formation of the above-mentioned cytotoxicproducts.

SUMMARY OF THE INVENTION

The object of the present invention is to solve the above-mentionedproblem.

According to the present invention this object is achieved by animproved method for preparing a medical solution, preferably aperitoneal dialysis solution, comprising the steps of:

-   -   a) providing a solution comprising one or more acetylated or        deacetylated amino sugars in at least none compartment of a        container in a concentration of 20-40% by weight, with the basis        of the solution in said at least one-compartment, and    -   b) terminal sterilisation of said at least one compartment and        the contents therein.

Further, the present invention relates two the solution used forpreparing the medical solution, and to a container containing saidsolution.

The present invention also relates to use of said solution for themanufacture of a medicament for peritoneal dialysis.

In another aspect the present invention relates to a method ofperforming peritoneal dialysis, wherein said method comprises theintroduction of said medicament for peritoneal dialysis into theperitoneal cavity of a patient.

Further disclosure of the objects, problems, solutions and features ofthe present invention will be apparent from the following detaileddescription of the invention with reference to the drawings and theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a graph showing the relationship between the inhibition ofcell growth (ICG) and the NAG concentration in a solution containing NAGduring sterilisation.

FIG. 2 is a bar diagram showing the effect of increased NAGconcentration of 1.5% and 30% for three different pH values.

FIG. 3 is a graph showing the fluorescence of heat sterilised NAGcontaining solutions at different pH values.

FIG. 4 is a graph showing the relationship between pH and inhibition ofcell growth (ICG) in a solution containing 1.5% NAG.

FIGS. 5 a-5 d are HPLC chromatograms showing the different decompositionpatterns between a heat sterilised NAG solution and a heat sterilisedglucose solution.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention is a development of the above mentioned teachingsand relates to a method for preparing a sterile medical solution,preferably a solution for peritoneal dialysis.

Experiments in which measurements of the percentage of inhibition ofcell growth (ICG) and fluorescence have been made at varying NAGconcentrations, and also at varying pH values, during terminal heatsterilisation are illustrated in FIGS. 1-4. The results of theexperiments imply that the concentration of the amino sugar/sugarsshould be optimised. The results also show that, in a preferredembodiment of the invention, also the pH of the amino sugar containingsolution should be decreased from the neutral level.

A simple, reliable and known way to study the cytotoxicity of substancesor of medical fluids is to test proliferation as in vitro inhibition ofcell growth (ICG) in cultured cells. Another method to get a roughestimation of the amount of amino sugars that is rearranged ismeasurement of the fluorescence.

More precisely, from the graph in FIG. 1 it can be seen that theinhibition of cell growth reaches a maximum with sterilisation of asolution containing about 5% NAG. With increasing NAG concentration theinhibition of cell growth decreases.

The bar diagram in FIG. 2 illustrates the effect of increased NAGconcentration at different pH values during terminal heat sterilisation.It can be seen that the percentage inhibition of cell growth is lowerafter terminal heat sterilisation at a pH of 3.0 than at a pH of 5.5 and7.2, and that the inhibition of cell growth is lower after a terminalheat sterilisation at a NAG concentration of 30% than at a NAGconcentration of 1.5% for all three pH values.

FIG. 3 shows the relationship between pH for a terminally heatsterilised NAG containing solution and the fluorescence, measured at anexcitation at 350 nm and an emission of 430 nm. The lowest fluorescenceis seen at around pH 4.

FIG. 4 shows the inhibition of cell growth in a solution containing 1.5%NAG.

It has also been found that a NAG containing solution sterilised at anoptimal pH around 2.5-3.5 from an in vitro toxicological point of viewis more compatible for humans than solutions giving a higher percentageof inhibited growth when sterilised at higher or lower pH values.

The term “terminal” sterilisation used herein is intended to mean thatthe product is sterilised in its final package by a sterilisation methodinvolving addition of energy, e.g. heating and/or radiation (see alsoEuropean Pharmacopoeia 1977, p 283, col 1, last paragraph, to col 2,first paragraph, and p 284, col 2, “Filtration”, for a detaileddescription of this term, as well as for a review of differentsterilisation techniques). Sterile filtration involves filtration of thesolution to be included in the product, and the solution is asepticallyfilled into the container. This does not secure the sterility requiredin this context, and sterile filtration can therefore not be used as asterilisation method for a medicament if it is possible to sterilise themedicament by terminal sterilisation.

The terminal sterilisation may include heat sterilisation and/orradiation sterilisation, but is preferably heat sterilisation effectedin an autoclave at a temperature of at least 100° C., preferably at 121°C. The sterilisation time may vary depending on the sterilisationtemperature, the type of container and the contents therein to besterilised. The radiation sterilisation may be either ionizing ornon-ionizing sterilisation. Examples of ionising sterilisation are gammaand beta radiation. An example of non-ionizing radiation sterilisationis UV radiation.

The method according to the present invention is preferably effected fora multicompartment container as disclosed in WO 99/27885 (Gambro AB). Inthe present invention, such a container comprises at least onecompartment containing a physiologically compatible pH adjusting anddiluting solution as well as at least one compartment containing asolution comprising one or more acetylated or deacetylated amino sugars,in the following called amino sugar solution for simplicity. The aminosugar solution may be present in only one compartment. The solutions inthe different compartments are heat sterilisable, and the wholecontainer can be heat sterilised in an autoclave with the solutions insitu in said compartments. The solutions in the separated compartments,which are delimited from each other during the sterilisation and thesubsequent storage, can be mixed after sterilisation to form a finallyprepared sterile medical solution, preferably a solution for peritonealdialysis. It may also be mixed with a terminally sterilised pH adjustingand diluting solution in at least one other terminally sterilisedcompartment of the container, thereby finally preparing the medicalsolution. Such a medical solution may be stored after terminalsterilisation up to longer periods of time before mixing with theterminally sterilised pH adjusting and diluting solution. The terminalsterilisation can however also be effected for separatedinterconnectable containers comprising the solutions to sterilise andprovided with connection means with sterile connecting valves forsterile connection. The separated containers can also be connectedalready during manufacture by means of a breakable seal, for example aconventional frangible pin.

In one preferred embodiment of the invention, the amino sugar in theamino sugar containing solution present in one or more of saidcompartments is N-acetylglucosamine (NAG) in a concentration of 15-40%by weight with the basis on the solution in each of said compartments,e.g. 15, 20, 25, 30, 35, and 40% by weight.

In another embodiment of the invention the medical solution comprisingone or more acetylated or deacetylated amino sugars in a concentrationof 15-40% by weight, preferably 20-40% by weight, most preferably atleast 30% by weight, has a pH of 2.0-5.0, preferably 2.5-3.5, mostpreferably 3.0, wherein the formation of cytotoxic substances during theterminal sterilisation step is substantially prevented.

The upper limit for the concentration for each amino sugar in thesolution is determined by its solubility therein.

The compartment comprising the amino sugar containing solution may alsocontain any organic acid or other pH stabilising agent in order tofurther stabilise the pH during sterilisation. The solutions of thedifferent compartments have such respective pH values, concentrationsand volumes that the finally prepared medical solution after mixing thesolutions of the compartments has a pH that is substantially neutral,i.e. a pH between 6.0 and 8.0, preferably about 7.4, and an amino sugarconcentration between 0.2 and 15.0%, preferably 0.5-6.0%, e.g. 0.5-2.0%by weight, with the basis on the finally prepared solution.

The volume of each compartment, as well as the proportion between thecompartments, is in practice not critical. Each compartment volumedepends on the volume of constituent to be present therein. In the mostpreferred embodiment, the compartment which accommodates the pHadjusting and diluting solution is larger than the compartment whichaccommodates the amino sugar containing solution and is also thecompartment in which the solution/solutions from the other compartmentsis/are mixed with the pH adjusting and diluting solution.

In a preferred embodiment the medicament to be prepared is a peritonealdialysis solution containing N-acetylglucosamine and having a pH of 7.4.

It should be noted that the decomposition pattern for an amino sugarsolution during heat sterilisation follows specific Maillard reactionsgiving several different toxic decomposition products. The decompositionpattern differs for e.g. a glucose solution during heat sterilisation,wherein different decomposition products are formed. This difference isillustrated in FIGS. 5 a-5 d, showing chromatograms when analysing 3-DGand 3,4-DGE in a NAG solution and in a glucose solution, respectively.The difference in degradation is likely due to that the NAG moleculescontains groups that allows the Maillard reaction to take place andtherefore create a large number of degradation products not seen in aglucose solution.

The term “amino sugar containing solution” used herein means a solutioncomprising one or more acetylated or deacetylated amino sugars involvedin the present invention chosen from N-acetylglucosamine (NAG),galactosamine, N-acetylgalactosamine, mannosamine, andN-acetylmannosamine in the form of monomers, oligomers and/or polymersthereof including chitin, and human glucosaminoglycans, as well asderivatives thereof. The most preferred amino sugar isN-acetylglucosamine (NAG). Thus, the acetylated or deacetylated aminosugars may be represented by only one of the amino sugars listed or by acombination thereof as well as derivatives thereof.

The term “derivatives thereof” used herein means derivatives of saidamino sugars having the same or essentially the same ability to formcytotoxic degradation products during sterilisation.

The term “pH adjusting and diluting solution” used herein means asolution to be mixed with, e.g. acting as a receiving medium for, theamino sugar containing solution and at the same time a solutionadjusting the pH of the solution after mixing with the amino sugarcontaining solution to essentially neutral, i.e. with a pH between forexample 6.0 and 8.0, preferably about 7.4.

The term “low levels of cytotoxic degradation products” used hereinmeans that the amount of degradation products from the amino sugars isso low in the medical solution prepared according to the presentinvention that it is not more toxic to cultured cells than dialysissolutions according to prior art.

The pH adjusting and diluting solution in the preferred embodimentcontains pH adjusting agents, such as salts of inorganic acids, organicacids, alkalic substances etc. in a pharmaceutically stable range.Inorganic acids include hydrochloride acid etc., organic acids includelactic acid, malic acid, acetic acid, succinic acid, maleic acid,pyruvic acid, citric acid, gluconic acid, etc., and alkalic substancesinclude sodium hydrate, sodium bicarbonate etc. Also, various aminoacids can be used as a pH-adjusting agent.

After sterilisation the amino sugar containing solution is finallyprepared for use by mixing it with the pH adjusting and dilutingsolution, optionally with solutions in other compartments of thecontainer. The medical solution, preferably a peritoneal dialysissolution, thus obtained may also comprise different electrolyte ions,e.g. sodium, potassium, calcium, magnesium, chloride, lactate, andbicarbonate ions, in concentrations which are biocompatible andsubstantially isotonic. The electrolytes may be originally present inthe pH adjusting and diluting solution, the amino sugar containingsolution and/or another solution in one or more other compartments ofthe container, depending on their compatibility during sterilisation andstorage, normally in the form of pharmaceutically acceptable salts. Theamount of cations in a peritoneal dialysis solution ready for use isgenerally 110 to 140 mEq/ml of sodium ions, to 0.05 mEq/l of potassiumions, 0 to 3 mEq/l of magnesium ions and 0 to 6 mEq/l of calcium ions.Preferably the amount of chloride ions is 80 to 144 mEq/l.

The peritoneal dialysis solution as a preferred embodiment of themedical solution according to the present invention may also compriseother physiologically compatible constituents, e.g. further osmoticagents, such as carbohydrates, preferably glucose, proteins andpeptides, preferably albumin, as well as antioxidants, such asbisulphite.

The peritoneal dialysis solution of the present invention describedabove is applicable not only to continuous ambulatory peritonealdialysis (CAPD) but also to intermittent peritoneal dialysis (IPD),continuous cyclic peritoneal dialysis (CCPD), and automated peritonealdialysis (APD). Moreover, it contains low levels of cytotoxicdegradation products from amino sugars.

The present invention also relates to a solution as such having theabove defined characteristics.

The present invention also relates to a container containing the aminosugar containing solution in at least one compartment, wherein saidsolution optionally has been sterilised and contains low levels ofcytotoxic degradation products.

Further, the present invention relates to use of the solution accordingto the present invention for the manufacture of a medicament forperitoneal dialysis, wherein it is mixed with a sterilised pH adjustingand diluting solution.

As stated above, the present invention also relates to a method ofperforming peritoneal dialysis, wherein said method comprises theintroduction of said medicament for peritoneal dialysis into theperitoneal cavity of a patient.

In order to illustrate different embodiments of the present invention,containers having different compartment constructions containing theconstituents for the preparation of a peritoneal dialysis solution willbe described in the Examples below, as well as the composition of thesolutions in each compartment. In the examples, N-acetylglucoseamine(NAG) is used as amino sugar, either in one or two compartments of thecontainer. The pH for the NAG containing solutions in each compartmentvaried between 2.0 and 5.0 before mixing and between 6.0 and 8.0 in thefinally prepared medical solution.

EXAMPLES Example 1

Compartment A Volume 100 ml Sodium 0-140 mM NAG 300 g/l Compartment BVolume 180 ml Sodium 0-140 mM NAG 300 g/l Compartment C Volume 1900 mlSodium 0-140 mM Lactate 40 mM Magnesium 0.25-0.75 mM Calcium 0.9-2.0 mM

Final composition when the contents of compartments A+C are mixed:Volume 2000 ml Sodium 0-140 mM NAG 15 g/l Lactate 38 mM Magnesium0.24-0.71 mM Calcium 0.85-1.9 mM

Final composition when the contents of compartments B+C are mixed:Volume 2080 ml Sodium 0-140 mM NAG 26 g/l Lactate 36.5 mM Magnesium0.22-0.68 mM Calcium 0.82-1.8 mM

Final composition when the contents of compartments A+B+C are mixed:Volume 2180 ml Sodium 0-140 mM NAG 38.5 g/l Lactate 34.9 mM Magnesium0.21-0.65 mM Calcium 0.78-1.7 mM

Example 2

Compartment A Volume 100 ml Sodium 0-140 mM NAG 300 g/l Compartment BVolume 180 ml Sodium 0-140 mM Glucose 500 g/l Compartment C Volume 1900ml Sodium 0-140 mM Lactate 40 mM Magnesium 0.25-0.75 mM Calcium 0.9-2.0mM

Final composition when the contents of compartments A+C are mixed:Volume 2000 ml Sodium 0-140 mM NAG 15 g/l Glucose 0 g/l Lactate 38 mMMagnesium 0.24-0.71 mM Calcium 0.86-1.9 mM

Final composition when the contents of compartments A+B+C are mixed:Volume 2100 ml Sodium 0-140 mM NAG 14.3 g/l Glucose 23.8 g/l Lactate 36mM Magnesium 0.23-0.68 mM Calcium 0.81-1.8 mM

Example 3

Compartment A Volume 60 ml Sodium 0-140 mM NAG 200 g/l Glucose 330 g/lCompartment B Volume 100 ml Sodium 0-140 mM NAG 200 g/l Glucose 330 g/lCompartment C Volume 1900 ml Sodium 0-140 mM Lactate 40 mM Magnesium0.25-0.75 mM Calcium 0.9-2.0 mM

Final composition when the contents of compartments A+C are mixed:Volume 1960 ml Sodium 0-140 mM NAG 6.2 g/l Glucose 10.1 g/l Lactate 38.8mM Magnesium 0.24-0.73 mM Calcium 0.87-1.9 mM

Final composition when the contents of compartments B+C are mixed:Volume 2000 ml Sodium 0-140 mM NAG 10.0 g/l Glucose 16.5 g/l Lactate38.0 mM Magnesium 0.24-0.71 mM Calcium 0.86-1.9 mM

Final composition when the contents of compartments A+B+C are mixed:Volume 2060 ml Sodium 0-140 mM NAG 15.5 g/l Glucose 25.6 g/l Lactate 37mM Magnesium 0.23-0.69 mM Calcium 0.83-1.8 mM

The invention has been described above with reference to preferredembodiments of the invention. A skilled person will recognise thatfurther combinations are possible. Modifications which are apparent to askilled person are intended to be incorporated within the scope of theinvention, which is limited only by the appended claims.

1. A method for preparing a medical solution, comprising the steps of:a) providing a solution comprising one or more acetylated ordeacetylated amino sugars in at least one compartment of a container ina concentration of 15-40% by weight, with respect to the weight of thesolution in said at least one compartment, and b) terminal sterilisationof said at least one compartment and the contents therein.
 2. The methodaccording to claim 1, wherein said one or more acetylated ordeacetylated amino sugars in said at least one compartment of saidcontainer are provided in a concentration of 20-40% by weight withrespect to the weight of the solution in said at least one compartment.3. The method according to claim 1, wherein said one or more acetylatedor deacetylated amino sugars are chosen from N-acetylglucosamine (NAG),galactosamine, N-acetylgalactosamine, mannosamine, andN-acetylmannosamine in the form of monomers, oligomers and/or polymersthereof, as well as derivatives thereof.
 4. The method according toclaim 3, wherein said one or more acetylated or deacetylated aminosugars is N-acetylglucosamine (NAG).
 5. The method according to claim 1,wherein the solution comprising said one or more acetylated ordeacetylated amino sugars in said at least one compartment of saidcontainer is provided at a pH of 2.0-5.0.
 6. The method according toclaim 5, wherein said pH is 25-3.
 7. The method according to claim 1,wherein the terminal sterilisation is heat sterilisation at atemperature of at least 100° C.
 8. The method according to claim 1,wherein each compartment of the container is delimited from theother/others during the terminal sterilisation, and wherein theterminally sterilised solution containing one or more acetylated ordeacetylated amino sugars is mixed with a terminally sterilised pHadjusting and diluting solution in at least one other terminallysterilised compartment of the container, thereby finally preparing themedical solution.
 9. The method according to claim 8, wherein the pH inthe finally prepared medical solution is 6.0-8.0.
 10. The methodaccording to claim 8, wherein the concentration of acetylated ordeacetylated amino sugars in the finally prepared solution is 0.2-15.0%by weight.
 11. The method according to claim 1, wherein physiologicallycompatible constituents in the form of carbohydrates proteins, peptides,and antioxidants are present in one or more of said compartments. 12.The method according to claim 1, wherein the medical solution preparedis a peritoneal dialysis solution.
 13. A solution comprising one or moreacetylated or deacetylated amino sugar/sugars in an amount of 15-40% byweight, wherein said solution is terminally sterilised and contains lowlevels of cytotoxic degradation products.
 14. The solution according toclaim 13, wherein the acetylated or deacetylated amino sugars are chosenfrom N-acetylglucosamine (NAG), galactosamine, N-acetylgalactosamine,mannosamine, and N-acetylmannosamine in the form of monomers, oligomersand/or polymers thereof, as well as derivatives thereof.
 15. Thesolution according to claim 13, wherein the pH of the solution is2.0-5.0.
 16. A container comprising at least one compartment containinga solution according to claim
 13. 17. A method for performing peritonealdialysis comprising mixing a solution according to claim 13 with aterminally sterilised pH adjusting and diluting solution and performingperitoneal dialysis with the resulting solution.
 18. The methodaccording to claim 2, wherein said one or more acetylated ordeacetylated amino sugars in said at least one compartment of saidcontainer are provided in a concentration of at least 30% by weight withrespect to the weight of the solution in said at least one compartment.19. The method according to claim 3, wherein said one or more acetylatedor deacetylated amino sugars are in the form of chitin or humanglucoseaminoglycans.
 20. The method according to claim 6, wherein saidpH is 3.0.
 21. The method according to claim 7, wherein the terminalsterilisation is heat sterilisation at a temperature of 121° C.
 22. Themethod according to claim 7, wherein the terminal sterilisation isradiation sterilisation.
 23. The method according to claim 9, whereinthe pH in the finally prepared medical solution is 7.4.
 24. The methodaccording to claim 10, wherein the concentration of acetylated ordeacetylated amino sugars in the finally prepared solution is 0.5-6.0%by weight.
 25. The method according to claim 11, wherein thecarbohydrate is glucose.
 26. A solution according to claim 13, whereinthe solution comprises one or more acetylated or deacetylated aminosugars in an amount of 20-40% by weight.
 27. A solution according toclaim 26, wherein the solution comprises one or more acetylated ordeacetylated amino sugars in an amount of at least 30% by weight. 28.The solution according to claim 14, wherein the acetylated ordeacetylated amino sugars are N-acetylglucosamine molecules.
 29. Asolution according to claim 15, wherein the solution has a pH of2.5-3.5.
 30. A solution according to claim 29, wherein the solution hasa pH of 3.0.